Multiplex lateral flow assay for differentiating bacterial infections from viral infections

A diagnostic test system comprising:

• an assay test strip comprising;
• a flow path configured to receive a fluid sample;
• a sample receiving zone coupled to the flow path;
• a detection zone coupled to the flow path downstream of the sample receiving zone, the detection zone comprising a first capture zone, a second capture zone, and a third capture zone, the first capture zone comprising a first immobilized capture agent specific to a first analyte of interest, the second capture zone comprising a second immobilized capture agent specific to a second analyte of interest, and the third capture zone comprising a third immobilized capture agent specific to a third analyte of interest;
• a first complex coupled to the flow path in a first phase and configured to flow in the flow path to the detection zone in the presence of the fluid sample in a second phase, the first complex comprising a label, a first antibody or a fragment thereof that specifically binds the first analyte of interest, and the first analyte of interest;
• a labeled second antibody or fragment thereof that specifically binds the second analyte of interest, the labeled second antibody or fragment thereof coupled to the flow path in the first phase and configured to flow in the flow path to the detection zone in the presence of the fluid sample in the second phase;
• and
• a labeled third antibody or fragment thereof that specifically binds the third analyte of interest, the labeled third antibody or fragment thereof coupled to the flow path in the first phase and configured to flow in the flow path to the detection zone in the presence of the fluid sample in the second phase
• a reader comprising a light source and a detector;
• and
• a data analyzer.